Construction and optimization of automatic checking mode for unit dose dispensing system of oral drugs / 中国药房

OBJECTIVE To provide a reference for establishing an automatic checking mode and improving the checking efficiency of the unit dose dispensing system of oral drugs in hospital. METHODS The automatic checking process reengineering team was established in our hospital. ECRSI method was adopted to sort out the verification process and mode of drug bags for the unit dose formula of our hospital through five principles of eliminating， combining， rearranging， simplifying and increasing， and the hardware series problem and the problem of excessive system false-positive proportion were optimized. The drug bags for the unit dose formula were randomly selected from 10 wards， the efficiency and external error rates of manual check and automatic checking mode before and after optimization were compared， and the false-positive reporting failure in automatic checking mode was also compared before and after optimization. RESULTS After the establishment of the automatic checking mode of the unit dose formula for oral drugs， the average checking time of drug bags was significantly shorter than that of manual checking mode in the other 8 wards except for cardiovascular and renal departments （P＜0.05）. After the optimization of the automatic checking mode， the average checking time of drug bags in all wards was significantly shorter than that in manual checking mode （P＜0.05）. Compared with before optimization of the automatic checking mode， the average checking time of drug bags was shortened by 0.43 s， and the average checking time of drug bags in half of the wards was shortened significantly （P＜0.05）. At the same time， the false-positive proportion decreased from 96.83% before optimization to 92.76% after optimization （P＜0.05）. The external error rate dropped from 0.039‰ in manual checking mode to 0.019‰ before optimization and 0.015‰ after optimization （P＜0.05）. CONCLUSIONS Based on ECRSI method， the automatic checking mode for the unit dose dispensing system of oral drugs can effectively reduce the average checking time of drug bags， reduce external error and improve the work efficiency of pharmacists.

Patent analysis of new target oral drugs for type 2 diabetes mellitus / 中国药房

OBJECTIVE To analyze the patents of new target oral drugs for type 2 diabetes mellitus （T2DM）， and to provide references for the research and development direction and patent layout of new domestic diabetes drugs. METHODS Based on global patent data in the HimmPat database， from multiple perspectives such as the number of patent applications and authorization， development trend， regional distribution and main applicants， statistics and analysis were performed for the patents related to 3 types of new target oral drugs for T2DM， such as glucokinase activator （GKA）， protein tyrosine phosphatase 1B inhibitor （PTP-1B-IN）， and 11β-hydroxysteroid dehydrogenase 1 inhibitor （11β-HSD1-IN）. RESULTS & CONCLUSIONS A total of 1 649 patents of GKA， 709 patents of PTP-1B-IN， 592 patents of 11β-HSD1-IN were obtained， the main applicants were well-known pharmaceutical companies， which possessed the core patents of pharmaceutical compounds. The research on GKA drugs was more mature， with a larger number of patent applications and a more comprehensive enterprise layout. Domestic enterprises， universities and research institutions had advantages in the field of PTP-1B-IN. Domestic enterprises and research institutions can leverage the advantages of traditional Chinese medicine and resources to enhance their research capabilities and improve technological competitiveness through core technology exploration， the exploration of process route， patent layout， industry- university-research cooperation and the establishment of patent pool.

Effects of glucosamine sulfate, chondroitin sulfate and diacerein on liver function in patients with Kashin-Beck disease / 中华地方病学杂志

Objective:To investigate the effects of glucosamine sulfate, chondroitin sulfate and diacerein on liver function in patients with Kashin-Beck disease.Methods:According to the criteria of "Diagnosis of Kashin-Beck Disease" (WS/T 207-2010), 333 cases of Kashin-Beck disease were selected from the disease severely affected areas, and randomly divided into 3 groups according to the matching principle of age, gender and disease grading: glucosamine sulfate group (group A, 118 cases), chondroitin sulfate group (group B, 99 cases) and diacerein group (group C, 116 cases), and the patients in each group were treated for 180 days. Fasting venous blood samples were collected from the patients in the three groups at 0, 90 and 180 days after treatment. Serum was separated. The biochemical analyzer was used to determine the serum levels of albumin (ALB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin (DBIL), glutamyl transpeptidase (GGT), total bilirubin (TBIL), and total protein (TP) of the three groups of patients.Results:There was no difference in the expression levels of 8 liver function indexes between the groups on day 0 of treatment ( P > 0.05). After 90 days of treatment, the expression level of GGT in group B was higher than that in group A ( P < 0.05); compared with 0 day of treatment, ALB levels of groups A, B and C were all decreased, ALP and TBIL levels increased ( P < 0.05), the abnormal expression rate of ALB index decreased in all the three groups ( P < 0.001), the abnormal expression rate of TBIL index in group A was decreased ( P = 0.006). After 180 days of treatment, ALB level of group B was higher than that of group A, ALP level of group B was higher than that of groups A and C, and AST level of group B was higher than that of group C ( P < 0.05); compared with 90 days of treatment, ALB levels of groups A, B and C were all increased, ALP, ALT and AST levels of groups A and C were decreased, GGT levels of groups B and C were decreased ( P < 0.05); compared with 0 day of treatment, the abnormal expression rate of ALB index increased in all the three groups at 180 days of treatment ( P < 0.001), and the abnormal expression rate of ALP index decreased in group C ( P = 0.031). Conclusion:The liver function indicators ALB, ALP and TBIL should be monitored when taking the three oral drugs for a short time, especially the GGT, ALP and AST indicators when taking chondroitin sulfate for a long time.

Pharmaceutical Care for Oral Medication of Tumor Patients with Dysphagia by Clinical Pharmacists / 中国药房

OBJECTIVE：To explore the mode of pharmaceutical care for oral medication of tumor patients with dysphagia by clinical pharmacists ，so as to promote clinical rational and safe drug use. METHODS ：Based on typical cases ，the problems existing in the oral medication of tumor patients with dysphagia were analyzed ，and the medication guidance and pharmaceutical care given by clinical pharmacists were expounded. RESULTS ：Clinical pharmacists found that tumor patients with dysphagia had some problems during oral medication ，such as improper administration position ，tube feeding of slow-controlled release preparations after opening the capsule ，limited administration route ，biting cytotoxic drugs ，unknown solubility of targeted drugs ，interaction of multiple drugs. In view of the above problems ，clinical pharmacists assisted physicians and nursing staff to provide pharmaceutical care to patients in combination with the patient ’s disease characteristics ，pharmacy，pharmacokinetics，pharmacodynamics，drug solubility，drug interaction and other factors ，such as skillfully using appropriate drug delivery location and mode ，using local drug delivery mode ，selecting appropriate dosage form based on pharmaceutical knowledge （the characteristics of new dosage form ）， guiding patients to use drugs correctly by being familiar with the characteristics of cytotoxic drugs and targeted drugs ，paying attention to potential drug interactions and guiding nurses to use drugs correctly. The situation of improper medication was improved. CONCLUSIONS ：Clinical pharmacists should participate in clinical therapy actively ，and make appropriate interventions with professional knowledge of pharmacy so as to promote the correct use of oral medication for tumor patients with dysphagia.

Formulation and evaluation of taste mask pellets of granisetron hydrochloride as oro dispersible tablet

Orally disintegrating systems have carved a niche amongst the oral drug delivery systems due to the highest compliance of the patients, especially the geriatrics and pediatrics. In addition, patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders prefer these medications because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated in these dosage forms. However, the requirements of formulating these dosage forms with mechanical strength sufficient to withstand the rigors of handling and capable of disintegrating within a few seconds on contact with saliva are inextricable. The purpose of this research was to mask the bitter taste of granisetron hydrochloride. To mask the taste Kollicoat(r) Smartseal 30D was used as coating polymer for pellet coating. The coated pellets of the drug was directly compressed with different superdisintegrant as AC-Di-Sol, Explotab and Kollidon CL in different concentration 5.0-7.5% w/w into an ODT. The prepared tablets were evaluated for hardness, friability, weight variation, wetting time, wet absorption ratio, in-vitro disintegration time and in vitro dissolution studies. Tablets exhibited quick disintegration characteristics with Kollidon CL in concentration 7.5% w/w i.e., within 20 seconds, which is characteristic of orally disintegrating dosage forms. More than 98% of drug was released from the formulations within 15 minutes. Formulations subjected to stability testing as per the ICH guidelines for 3 months, indicated stability with no change in taste, hardness, drug content, disintegration time and dissolution profiles. Thus, the results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated dosage forms in the oral cavity.

Sistemas de desintegração oral têm um nicho entre os sistemas de administração de medicamentos por via oral devido à maior aceitação dos pacientes, especialmente os de geriatria e pediatria. Além disso, pacientes que sofrem de disfagia, enjoo de movimento, emese repetida e distúrbios mentais preferem estes medicamentos porque não podem engolir grande quantidade de água. Além disso, os fármacos que exibem absorção satisfatória a partir da mucosa oral ou que se destinam a ação farmacológica imediata podem ser vantajosamente formulados nestas formas de dosagem. No entanto, a formulação destas formas farmacêuticas exige-lhes resistência mecânica suficiente para suportar os rigores do manuseio e capacidade de desintegrar dentro de alguns segundos em contato com a saliva. O objetivo desta pesquisa foi o de mascarar o gosto amargo de cloridrato de granisetrona. Para mascarar o sabor, utilizou-se Kollicoat smartseal 30D como polímero para io revestimento dos péletes. Os péletes revestidos do fármaco foram diretamente comprimidos com superdesintegrante diferente como Ac-Di-Sol, Explotab e Kollidon CL, em diferentes concentrações 5.0-7.5% m/m em comprimidos de dispersão oral (ODT). Os comprimidos preparados foram avaliados quanto à dureza, friabilidade, variação de peso, ao tempo de umedecimento, à razão de absorção de umidade, ao tempo de desintegração in vitro e em estudos de dissolução in vitro. Os comprimidos apresentaram características de desintegração rápida com Kollidon CL, em concentração de 7,5% m/m, ou seja, dentro de 20 segundos, o que é característico para formas farmacêuticas de desintegração oral. Mais do que 98% do fármaco foi liberado a partir das formulações no prazo de 15 minutos. Formulações submetidas a testes de estabilidade de acordo com as diretrizes da ICH por 3 meses indicaram estabilidade sem alteração no sabor, dureza, teor de fármaco, tempo de desintegração e perfis de dissolução. Assim, os resultados demonstraram que o mascaramento de gosto foi bem-sucedido e atingiu-se rápida desintegração das formas de dosagem na cavidade oral.

The impact of therapeutic regimen on the depression in type 2 diabetes mellitus: A cross-sectional study / 中华内分泌代谢杂志

To explore the depression in type 2 diabetic patients treated with insulin and compared to those treated with oral anti-diabetic drugs.283 type 2 diabetics were seclected randomly from outpatient and inpatient departments of endocrionology in Jiangsu Province Hospital of Traditional Chinese Medicine,with the self-designed questionnaire and Zung self-rating depression scale to conduct the survey.Comparisons between the two groups were carried out with t-test or x2 test for quantitative and qualitative data,respectively.Logistic regression were used for the analysis of the relationship between the therapeutic regimen and depression.Overall,43.1％ of the type 2 diabetic subjects showed depressive symptoms in different degrees.Compared to the oral drug group,the insulin group showed a significantly higher prevalence of depressive symptoms (insulin group,53.5％,oral drug group,30.5％;P＜0.01)and higher self-rating depression scale scores (insulin group,51.7 ± 12.4,oral drug group,44.8 ± 10.6;P＜0.01).Moreover,after an adjustment for age,sex,body mass index,diabetic duration,complications,HbA1Cand so on,the insulin group showed a significantly higher frequency of depression (OR=4.218,95％ CI 1.764-13.285,P=0.004),compared to the oral drug group.The data showed that insulin treatment is an independent risk factor to the presence of depressive symptoms in type 2 diabetics,and it is necessary to pay more attention to their psychological support.

Analysis on Oral Drugs in Multiple-unit Container / 中国药房

OBJECTIVE:To study the rationality of multiple-unit containers of oral drugs.METHODS:The condition of whether the oral western medicines currently used in our hospital were packaged in single-dose container or not were inves?tigated;the information on packaging and distribution of multiple-unit containers was analyzed as well.RESULT:Of the460kinds of oral western medicines investigated,220were in single-dose containers,and138were in multiple-unit containers,of the multiple-unit containers87involved problems in packaging.CONCLUSION:It is suggested that single-dose container should be used and the multiple-unit containers should be improved reasonably.

Comparison of Testing Results for Coliform Bacteria and Escherichia Coli in Oral Drugs / 中成药

Objective: To compare with coliform bateria and Escherichia coli testing results in oral drugs. Methods: 24 species Chinese herb medicines and 35 kinds of Chinese traditional patent medicines in 68 batches were examined by using the method of coliform bacteria and escherichis coli test.Results: There were significant differences. Conclusion: The result showed that using the coliform bacterias as the hygienic indicative bacteria was significant.